A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

May 11, 2021

Primary Completion Date

October 2, 2023

Study Completion Date

September 30, 2027

Conditions
In-Stent Restenosis
Interventions
DEVICE

AGENT DCB

Drug coated PTCA balloon catheter

DEVICE

PTCA balloon catheter

PTCA balloon catheter

Trial Locations (40)

10032

Columbia University Medical Center, New York

10467

Montefiore Medical Center, New York

11576

St. Francis Hospital, Roslyn

17053

UPMC Pinnacle Health, Wormleysburg

22042

Inova Fairfax Hospital, Falls Church

22908

University of Virginia Medical Center, Charlottesville

27610

Wake Medical Center, Raleigh

30046

Northside Hospital, Lawrenceville

30060

Wellstar Kennestone Hospital, Marietta

30322

Emory University Hospital, Atlanta

32308

Tallahassee Memorial Hospital, Tallahassee

35233

University of Alabama at Birmingham, Birmingham

37203

Centennial Medical Center, Nashville

38104

Methodist North Hospital, Memphis

44195

Cleveland Clinic Foundation, Cleveland

45219

Lindner Center for Research and Education at Christ Hospital, Cincinnati

48202

Henry Ford Hospital, Detroit

55101

Regions Hospital, Saint Paul

60201

Evanston Hospital, Evanston

64111

St. Luke's Hospital of Kansas City, Kansas City

66211

Overland Park Regional Medical Center, Overland Park

68124

Bergan Cardiology, Omaha

70121

Ochsner Medical Center, New Orleans

75226

Baylor Heart and Vascular Hospital, Dallas

77030

Houston Methodist Hospital, Houston

78756

Heart Hospital of Austin, Austin

80210

South Denver Cardiology, Littleton

80216

St. Anthony Hospital, Lakewood

85745

Carondelet Medical Group St. Mary's Hospital, Tucson

90048

Cedars Sinai Medical Center, Los Angeles

92037

University of California San Diego, La Jolla

94121

San Francisco Veterans Affairs Medical Center, San Francisco

94305

Stanford University Medical Center, Stanford

98195

University of Washington, Seattle

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

07753

Jersey Shore University Medical Center, Neptune City

02903

Rhode Island Hospital, Providence

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY